UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026375
Receipt number R000030310
Scientific Title Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Date of disclosure of the study information 2017/03/02
Last modified on 2021/06/28 16:44:57

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Basic information

Public title

Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Acronym

Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.

Scientific Title

Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Scientific Title:Acronym

Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.

Region

Japan


Condition

Condition

Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Basic objectives2

Others

Basic objectives -Others

Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.

Key secondary outcomes

Relationship between variation of bacterial flora and therapeutic effect, AEs or PD-L1 expression.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically proven non-small cell lung cancer
2)Pretreated NSCLC, without immune chekpoint inhibitor
3)ECOG PS : 0-2
4)When taking lactobacillus preparation (including marketing medicines), it can be canceled from one week before registration to the end of observation period.
5)At least one measurable lesion by RECIST
6)Life expectancy more than 12 weeks.
7)Written informed consent.
8)Patients who have had the following administration periods from the previous treatment
A.chemotherapy:Not specified
B.radiation
chest: >4weeks
Other than chest: >2 weeks
C.surgery
major: >4weeks
minor: >2weeks

Key exclusion criteria

1)With active or history of Interstitial pneumonia.
2)Interstitial change or pulmonary fibrosis detectable on X ray
3)Autoimmune disease.
4)Patients receiving corticosteroids (up to 10 mg/day in terms of prednisolone is acceptable) or immunosuppressants within 2 weeks before registration.
5)Patients receiving antibiotics within 5 weeks before registration
6)Patients who are pregnant or nursing
7)With active or history of inflammatory bowel disease.
8)Evaluated to be ineligible by a physician for other reasons.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name TAKASHI
Middle name
Last name YOKOI

Organization

Hyogo College of Medicine

Division name

Department of Thoracic Oncology

Zip code

663-8501

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6596

Email

ta-yokoi@hyo-med.ac.jp


Public contact

Name of contact person

1st name RYO
Middle name
Last name ITOTANI

Organization

Kitano Hospital

Division name

Respiratory medicine

Zip code

530-8480

Address

2-4-20, Ogimachi, Kita-ku, Osaka-city

TEL

06-6312-1221

Homepage URL


Email

itotani@kitano-hp.or.jp


Sponsor or person

Institute

Kansai Clinical Oncology Group

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Review Board of Hyogo College of Medicine

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

Tel

0798-45-6111

Email

rinri@hyo-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

兵庫医科大学病院、関西医科大学附属病院、北野病院


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 02 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000030310

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000030310

Number of participants that the trial has enrolled

32

Results

・Primary
1. Relationship between DCR and gut microbiota. : No significant difference was observed in all bacterial species.
2. Relationship between ORR and gut microbiota.:
Clostridium subcluster XIVa showed a significant correlation (HR:1.146, 95% C.I.:1.025-1.282, p=0.0165). But no significant difference was found in other species.
・Secondary
Relationship between ORR and changes in gut microbiota.: No significant difference was observed in all bacterial species.

Results date posted

2021 Year 06 Month 28 Day

Results Delayed

Delay expected

Results Delay Reason

Result analysis and treatise writing are delayed.

Date of the first journal publication of results


Baseline Characteristics

Patient characteristics of 27 patients whose consent was obtained and whose stool samples could be collected and analyzed.

Median age: 70 years (46-88)
Gender: 25 males, 2 females
Stage: III 8 cases, IV 13 cases, postoperative recurrence 6 cases
Smoking history: 25 smoker, 2 non-smoker
Gene mutation: Yes 3 cases, No 20 cases, Unknown 4 cases

Participant flow

This study is multicenter observational study to evaluate the relationship between gut bacterial flora and therapeutic effects and/or adverse events in advanced non-small cell lung cancer patients treated with nivolumab.

Adverse events

Fatigue; Grede1: 5 cases (15.6%)
ILD; Grade 1: 3 cases (8.6%), Grade 3: 1 case (2.9%)
Hypothyroidism; Grade 1: 5 cases (15.6%), Grade 2: 1 case (2.9%)
Rash; Grade 1: 4 cases (11.4%)
Stomatitis; Grade1: 1 case (2.9%)
Diarrhea; Grade 1: 1 case (2.9%)
Liver damage; Grade 3: 1 case (2.9%)
Constipation; Grade 1: 1 case (2.9%), Grade 2: 1 case (2.9%)
Acute exacerbation of COPD; Grade 3: 1 case (2.9%)

Outcome measures

Primary objectives;
To evaluate the relationship between intestinal gut bacterial flora and therapeutic effect and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Secondary objectives;
To evaluate the relationship between the alteration of gut bacterial flora and therapeutic effects and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017 Year 01 Month 21 Day

Date of IRB

2017 Year 09 Month 08 Day

Anticipated trial start date

2017 Year 03 Month 02 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information

Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.


Management information

Registered date

2017 Year 03 Month 02 Day

Last modified on

2021 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030310


Research Plan
Registered date File name
2021/06/16 KCOG1615研究計画書v3.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/04/22 20190422.xlsx